BiliLux (2019-08-21)

Starting date:

August 21, 2019

Posting date:

January 10, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72065

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

BiliLux

Reason

Total irradiance of the phototherapy light of the BiliLux is exceeding the total irradiance limits published in the product IFU. The led light intensity from the supplier has increased over time since the initial production of the BiliLux in 2017. Current design of the BiliLux does not allow the manufacturer to maintain the total irradiance within the published range.

Affected products